Regulation of the Minister of Marine Affairs and Fishery of R.I. No. PER.04/MEN/2012 on fish medication

SOV IAMPZCI;"47' jk:,I*NINPaV "e GUVERJ.L'AE'rr RE CULATICM'S FISH MEDICATION (The Regulation of Minister of Marine Affairs and Fishery of R.I Number PER.04/MEN/2012, 31 January 2012) BY THE GRACE OF ONE AND ALMIGHTY GOD THE MINISTER OF MARINE AND FISHERY THE REPUBLIC OF INDONESIA, Considering: a. that in order to protect fish, environment, and hu man health resources, it is necessary to review the Decree of Minister of Maritime Affairs and Fisheries Number KEP.26/MEN/2002 concerning Provision, Circulation, Usage, and Supervision of Fish Medicine; Supplementary State Gazette of Republic of Indo nesia Number 5073); 3. Law Number 32 Year 2004 (BN No. 7152 page 9B-18B) concerning Local Governance (State Ga zette of Republic of Indonesia Year 2004 Number 128, Supplementary State Gazette of Republic of Indonesia Number 4437), as has been amended for the last time with the Law Number 12 Year 2008 (State Gazette of Republic of Indonesia Year 2008 Number 59, Supplementary State Ga zette of Republic of Indonesia Number 4844); b. that therefore it is necessary to stipulate Minister 4. Law Number 18 Year 2009 concerning Animal Regulation concerning Fish Medicine; In view of: 1. Law Number 16 Year 1992 (BN No. 5292 page 4B-13B) concerning Quarantine of Animals, Fish, and Plants (State Gazette Year 1992 Number 56, Supplementary State Gazette Number 3482); 2. Law Number 31 Year 2004 (BN No 7144 page 7B-12B) concerning Fisheries (State Gazette of Husbandry and Health (State Gazette of Republic of Indonesia Year 2009 Number 84, Supplemen tary State Gazette of Republic of Indonesia Num ber 5015); 5. Government Regulation Number 78 Year 1992 concerning Animal Medicine (State Gazette of Republic of Indonesia Year 1992 Number 129, Supplementary State Gazette of Republic of Indo nesia Number 3509); Republic of Indonesia Year 2004 Number 118, 6. Government Regulation Number 15 Year 2002 Supplementary State Gazette of Republic of Indo- concerning Fish Quarantine (State Gazette of Re nesia Number 4433), as has been amended with the Law Number 45 Year 2009 (State Gazette of Republic of Indonesia Year 2009 Number 154, public of Indonesia Year 2002 Number 36, Sup plementary State Gazette of Republic of Indone sia Number 4197); Business News 8337111-30-2012 I 19 7. Government Regulation Number 38 Year 2007 (BN No. 6776 page 3B-12B) concerning Divi sion of Governmental Affairs Among Govern ment, Province Government and District/City Government (State Gazette of Republic of In donesia Year 2007 Number 82, Supplementary State Gazette of Republic of Indonesia Number 4737); 8. President Regulation Number 47 Year 2009 con cerning Formation and Organization of State Min DECIDED: To stipulate: REGULATION OF MINISTER OF MARINE AFFAIRS AND FISHERY CONCERNING FISH MEDICINE. CHAPTER I GENERAL PROVISIONS Article 1 In this Minister Regulation there are defini istry, as has been amended with President Regu- tions as follows: lation Number 76 Year 2011; 1. Provision is activity of fish medicine provision or 9. President Regulation Number 24 Year 2010 con cerning Positions, Duties, and Functions of State Ministry As Well As The Order Of Organization, Duties, And Functions Of Echelon I State Minis try, as has been amended with President Regula tion Number 92 Year 2011; 10. Presidential Decree Number 84/P Year 2009, as has been amended with Presidential Decree Num ber 56/P Year 2010; 11. Regulation of Minister of Marine Affairs and Fish fish medicine raw material done through manu facturing in domestic and/or supply from a broad. 2. Circulation is activity in the framework of distri bution ad delivery of fish medicine whether in the framework of trade as well as non-trade. 3. Fish medicine raw material is all chemical materi als or substance in the form of active material, additional material, and/or auxiliary material in the form of single component, batch/partially finished product used to make fish medicine. ery Number PER.20/MEN/2007 concerning Quar- 4. Fish Medicine is preparation that can be used to antine Action For Quarantined Fish Pest And Dis- treat fish, to free from symptoms, or to modify ease Import Media From Abroad And From An Area Into Another Area Within The Territory Of Republic Of Indonesia; 12. Regulation of Minister of Marine Affairs and Fish ery Number PER.15/MEN/2010 concerning the Organization and Management of the Ministry of Marine Affairs and Fishery; chemical process in the body that includes bio logical, pharmaceutical, premix, probiotics, and natural medicine. 5. Fish is all types of organism that the whole or part of their life cycle takes place in aquatic environ ment. 6. Etiquette is direct writing or writing amounted 20 Business News 8337/11-30-2012 on container or wrap that contains fish medicine marking. 7. Brochure is sheet made of paper or other material that contains complete marking of fish medicine enclosed in the outer container or wrap. 8. Package is numeral that shows volume or weight or certain amount of a fish medicine preparation in a container whether it is wrapped in or not. 9. Person is an individual person or corporation 10. Corporation is a well organized group of people and/or wealth in the form of legal entity or non legal entity. 11. Fish medicine producer is the person who makes fish medicine for commercial purpose. 12. Fish medicine importer is the person who per forms fish medicine import from abroad. 13. Fish medicine importer is the person who per forms fish medicine import from abroad. that must be obtained by a person who wants to run fish medicine business. 17. Fish quarantine officer is certain civil servant who is given duty to perform quarantine action based on the laws. 18. Fish Health Expert is someone who gets knowl edge concerning fish health through formal edu cation. 19. Minister is the Minister of Maritime Affairs and Fisheries. 20. Director General is Director General of Fish Culti vation. 21. Provincial or Regency/Municipal Office is the of fice with authorities and liabilities in fisheries field. Article 2 The scope of this Minister Regulation in 14. Fish medicine distributor is the person who per- cludes: forms fish medicine circulation business from pro ducer or importer to depot and/or to fish medicine shop. 15. Producer Importer Identification Number herein after abbreviated as API-P is producer importer identification number issued by Director Gener al of Foreign Trade of Ministry of Trade to im porter who performs goods import for personal use and/or to support production process and is not allowed to be traded or transferred to other party. a. fish medicine raw material; b. fish medicine business; c. purpose of use, preparation, and classification of fish medicine; b. fish medicine provision; e. fish medicine registration; procedures for import of raw material of fish med icine, fish medicine sample, and fish medicine; g. import and export ports; h. circulation; i. re-import; and 16. Fish medicine business license is written license j. guidance, monitoring, and supervision. Business News 8337/11-30-2012 21 •• • • ••••••- •••••-••••!•11juirillit.:1111. 111111;,8111 CHAPTER II FISH MEDICINE RAW MATERIAL Article 3 (1) Provision of fish medicine raw material through import from foreign country can only be done by importer with API-P or government/private institu tion. (2) Provision of fish medicine raw material by govern ment/private institution as meant at paragraph (1) is done only for research interest. (3) Fish medicine raw material that comes from for eign country can be entered into the territory of the State of Republic of Indonesia after obtaining Statement Letter of Fish Medicine Raw Material Import. (4) In order to obtain Statement Letter of Fish Medi cine Raw Material Import as meant at paragraph (3), government/private institution or importer must apply written application to Director General that at least contains: a. name of fish medicine raw material; b. name and the applicant; c. name of fish medicine raw material producer; d. country of origin of fish medicine raw mate rial; e. form of fish medicine raw material; f. preparation type of fish medicine raw mate j. loading port; and k. entry port. (5) Application as meant at paragraph (4), is carried out by attaching the following documents: a. Certificate of Analysis (CoA); b. Certificate of Origin (Co0) validated by Repre sentative of Republic of Indonesia in the coun try of origin of fish medicine raw material; and c. Certificate of Free Sale. (6) Director General or official appointed to perform document evaluation within 3 (three) working days since the date of acceptance of the com plete documents. (7) Based on document evaluation as meant at para graph (6), Director General or appointed official issue: a. Statement Letter of Fish Medicine Raw Mate rial Import; or b. Rejection Letter of Fish Medicine Raw Mate rial Import, along with reason to reject. (8) Statement Letter of Fish Medicine Raw Material Import as meant at paragraph (7) point a at least contains: a. name of fish medicine raw material; b. name and address of importer of government/ private institution; c. name of fish medicine raw material producer; rial; d. country of origin of fish medicine raw mate g. package size; rial; h. purpose of fish medicine raw material import; e. form of fish medicine raw material; I. amount of fish medicine raw material; f. preparation type of fish medicine raw material; 22 Business News 8337/11-30-2012 .74WKIVINWEINXiMNYN,N6Ot GaVER Ni.AENT R [ CLL"T i rjr 1 S iatatireigiaWneicONtreM g. package size; h. purpose of fish medicine raw material import; i. amount of fish medicine raw material; j. loading port; k. entry port; and I. effective term of Statement Letter of Fish Medicine Raw Material Import. (9) Statement Letter of Fish Medicine Raw Material Import as meant at paragraph (7) point a can only be used for 1 (one) time import and valid for 3 (three) months since the issuance date. (10) Form and format of Statement Letter of Fish Medicine Raw Material Import are as stated on Attachment I as inseparable part of this Minister Regulation. Article 4 (1) Exporter who will export fish medicines raw ma terial from the territory of State of Republic of Indonesia must have Statement Letter of Fish Medicine Raw Material Export (2) In order to obtain Statement Letter of Fish Medi cine Raw Material Export as meant at paragraph (1), exporter must apply written application to Di rector General that at least contains: a. name of fish medicine raw material; b. name and address of the applicant; c. name of fish medicine raw material producer; d. country of destination; e. form of fish medicine raw material; f. preparation type of fish medicine raw mate rial; g. package size; h. purpose of fish medicine raw material export; I. amount of fish medicine raw material; and lc exit port. (3) Director General or official appointed to perform evaluation within 3 (three) working days since the acceptance date of complete application. (4) Based on evaluation result as meant at paragraph (3), Director General or appointed official issues: a. Statement Letter of Fish Medicine Raw Mate rial Export; or b. Rejection Letter of Fish Medicine Raw Mate rial Export, along with reason to reject. (5) Statement Letter of Fish Medicine Raw Material Export as meant at paragraph (4) point a, at least contains: a. name of fish medicine raw material; b. name and address of the exporter; c. name of fish medicine raw material producer; d. country of destination; e. form of fish medicine raw material; f. preparation type of fish medicine raw mate rial; g. package size; h. purpose of fish medicine raw material export; i. amount of fish medicine raw material; j. exit port; and k. effective term of Statement Letter of Fish Medicine Raw Material Export. Business News 8337/ 11-30-2012 1 23 •Pc aZinliiiiii((ii1Iaicltrlt;i(a11111111k (6) Statement Letter of Fish Medicine Raw Material e. fish medicine exporter; Export as meant at paragraph (4) point a can only b. fish medicine distributor; be used for 1 (one) time export and valid for 3 , e. fish medicine depot; and (three) months since the issuance date. f. fish medicine shop. (7) Form and format of Statement Letter of Fish , (2) Provision of fish medicine can be done by govern Medicine Raw Material Export are as stated on Attachment II as inseparable part of this Minister Regulation. CHAPTER III FISH MEDICINE BUSINESS Article 5 (1) Fish medicine business consists of: a. fish medicine provision business; and b. fish medicine distribution business. (2) Fish medicine provision business as meant at paragraph (1) point a includes the activity of fish medicine making from preparation of raw material until it becomes fish medicine and/or fish medi cine entry from foreign country. (3) Fish medicine distribution business as meant at paragraph (1) point b includes the activity that related to trade, transportation, and delivery of fish medicine. Article 6 ment/private institution for research interest. Article 7 ( 1 ) Fish medicine provision business as meant in Ar ticle 5 paragraph ( 1 ) point a is performed by pro ducer or importer. (2) Fish medicine distribution business as meant in Article 5 paragraph (1) point b is performed by ex porter, distributor, depot, or fish medicine shop. (3) Every individual who performs fish medicine busi ness as meant in the Article 5 paragraph (1) is obliged to have Fish Medicine Business License. (4) Extending laws concerning authority, require ments, and procedures of Fish Medicine Business License are regulated with Minister Regulation. CHAPTER IV PURPOSE OF USE, PREPARATION, AND CLASSIFICATION OF FISH MEDICINE Article 8 Purpose of use of fish medicine at least in cludes: (1) Every individual who performs fish medicine busi- a. to prevent, to reduce, and to remove fish disease ness, is grouped as: symptoms; a. fish medicine producer; b. to diagnose and to cure fish disease; b. fish medicine importer; c. to help calming and numbing fish; 24 Business News 8337/11-30-2012 d. to increase fish reproduction; e. to overcome deficiency of vitamin and mineral f. to beautify color and body of fish; g. to maintain and/or to increase water quality for aquaculture; and/or h. to maintain and/or to improve fishery product quality. Article 9 Fish medicines according to type or prepara tion are grouped into: a. biologic; b. pharmaceutics; c. premix; d. probiotics; and e. natural medicine. Article 10 (1) Fish medicine of biologic preparation type as meant in Article 9 point a is resulted through biological process in animal or animal tissue to create immu nity, to diagnose disease, or to cure disease with immunologic process, namely vaccine, sera (anti sera), antigen, and biologic diagnostic material. (2) Fish medicine of pharmaceutics preparation type as meant in Article 9 point b is resulted from inor ganic as well as organic material, and/or chemical synthesis reaction used based on pharmacologi (3) Fish medicine of premix preparation type as meant in Article 9 point c is fish medicines used as feed additive and feed supplement given by mixing it with fish feed, consists of feed additive and feed supplement. (4) Feed additive as meant at paragraph (3) is ad ditional material for feed that naturally does not contain nutrient and the purpose of using is to beautify fish color, to aromatize feed, and to pre serve feed. (5) Feed supplement as meant at paragraph (3) is a substance that naturally exists in the feed, but the amount needs to be increased by adding namely amino acid, vitamin, and mineral into the feed. (6) Fish medicine of probiotics preparation as meant in Article 9 point d, is resulted from non-patho genic microbes that naturally exist in water envi ronment and in fish body that work with process of bioremediation, biocontrol of digestive tract and as competitor for pathogenic bacteria, name ly Bacillus Subtillis, Lactobacillus, Nitrosomonas, and Nitrobacteria. (7) Fish medicine of natural medicine preparation as meant in Article 9 point e, is ingredient or concoc tion of ingredients in the form of original material of plant, animal, mineral, galenic preparation, or mixture of those ingredients without addition of chemical substance with medication power and cal work power, namely hormones, antibiotics, the benefits are only based on empirical data and antibacterial, chemotherapeutic, anti parasite, there is no complete clinical data, namely meniran anti fungus, anthelmintics, and anesthetics. leaf extract and sambiloto leaf extract. Business News 8337/11-30-2012 25 Zizz; ern''•" • •'" • 4's • "'• • Article 11 paragraph (3) are regulated with Minster Regula (1) Fish medicine based on classification of danger tion. that may occur in the use, classified into: a. Prescription drugs, is fish medicine that if Article 13 the use is not in accordance to the rules can (1) Fish medicine prevision with biologic, probiotics, cause risk for fish environment, and/or human and natural medicine preparation must fulfill the who consumes the fish; b. Limited free drugs, is prescription drugs for fish that treated as free drugs for certain kind of fish provided that it is prepared with cer tain amount, dose rule, form of preparation, and marked with special warning; and c. Over the counter drugs, is fish medicine that can be obtained and used without prescrip tion from veterinarian and/or recommendation from fish health expert. (2) Extending laws on the fish medicine classification as meant at paragraph (1) are stipulated with Min ister Regulation. CHAPTER V FISH MEDICINE PROVISION Article 12 (1) Fish medicine provision is done through domestic manufacturing and entry from aboard. (2) Fish medicine provision is done by giving priority to domestic manufacturing. (3) Fish medicine provision through domestic manu facturing is done in accordance to Good Manufac turing Practice (CPOIB). following rules: a. fish medicine of biologic preparation type can be done for fish disease types exist in Indonesia; b. fish medicine of probiotics in one preparation at maximum contains 5 species of microbes with density of each species at least 106 cfu/ ml; and/or c. fish medicine of natural medicine preparation in one preparation at maximum contains 5 (five) types of simplicia. (2) Fish medicine preparation of biologic preparation type for diagnose of disease of non-existent dis ease in Indonesia, can be done if it does not con tain living microbe and/or part of it that carries pathogenic element. CHAPTER VI FISH MEDICINE REGISTRATION First Part General Article 14 (1) Fish medicine provided by producer or importer must have Fish Medicine Registration Letter. (2) Obligation to have Fish Medicine Registration Let (4) Extending laws concerning CPOIB as meant at ter as meant at paragraph (1), is excluded for: 26 Business News 8337/11-30-2012 GoVERNmENT R Ns a. fish medicine provided by government/private institution; or b. natural medicine with simple process, does not contain prescription medicine, and used for own interest. Second Part Mechanism Article 15 (1) In order to obtain Fish Medicine Registration Let ter as meant in Article 14 paragraph (1), producer or importer must apply written application to Di rector General along with: a. quality examination result report; b. field trial result report, for fish medicine that and showing the original; e. copy of Letter of Agency/Distributor Appoint ment from producer overseas to importer company in Indonesia, and showing the origi nal; and f. copy of Statement Letter of Fish Medicine Sample Entry. (3) Certificate of Good Manufacturing Practice as meant at paragraph (2) point c, is at least equal to CPOIB. Article 16 (1) Quality examination and field trial as meant in Ar tide 15 paragraph (1) point a and point b are per formed on fish medicine sample. requires field examination; and (2) Fish medicine sample that comes from foreign c. fish medicine technical data. country can be entered into the territory of the (2) Application for Fish Medicine Registration Letter State of Republic of Indonesia after obtaining for fish medicine from entry from abroad, aside Statement Letter of Fish Medicine Sample Entry. from enclosing requirements as meant at para- I (3) In order to obtain Statement Letter of Fish Medi graph (1), must be completed with: a. copy of Certificate of Origin, and showing the original; b. copy of Certificate of Free Sale, and showing the original; c. copy of Certificate of Good Manufacturing Practice from authority institution from the country of origin, and showing the original; d. copy of Certificate of Non-Genetically Modi cine Sample Entry as meant at paragraph (2), im porter must apply written application to Director General that at least contains: a. trade mark/brand of fish medicine sample; b. name and address of the applicant; c. name of fish medicine sample producer; d. country of origin of fish medicine sample; e. composition of fish medicine sample; f. form of fish medicine sample; tied Organism, for fish medicine of biologic g. preparation type of fish medicine sample; preparation that is not modified genetically, h. package size; Business News 8337/11-30-2012 27 i. purpose of entry; j. amount of fish medicine sample; k. loading port; and I. entry port. 141 Application as meant at paragraph (3), is carried out by attaching the following documents a. Certificate of Analysis (C0A); b. Certificate of Origin 1Co01 validated by Repre sentative of Republic of Indonesia in the coun try of origin of fish medicine sample; c. Certificate of Free Sale; and d. Certificate of Non-Genetically Modified Organ ism, for fish medicine of biologic preparation that is not modified genetically. (5) Director General or official appointed to perform document evaluation within 3 (three) working days since the date of acceptance of the com plete documents. (6) Based on document evaluation as meant at para graph (5), Director General or appointed official issues: a. Statement Letter of Fish Medicine Sample En try; Or b. Rejection Letter of Fish Medicine Sample En try, along with reason of rejection. (7) Statement Letter of Fish Medicine Sample Entry as meant at paragraph (6) point a contains: a. trade mark/brand of fish medicine sample; b. name and address of the importer; c. name of fish medicine sample producer e. composition of fish medicine sample; f. form of fish medicine sample; g. preparation type of fish medicine sample; h. package size; i. purpose of entry; j. amount of fish medicine sample; k. loading port; I. entry port; and m. effective term of Statement Letter of Fish Medicine Sample Entry. (8) Statement Letter of Fish Medicine Sample Entry as meant at paragraph (6) point a can only be used for 1 (one) time entry and valid for 1 (one) month since the issuance date. (9) Form and format of Statement Letter of Fish Medicine Sample Entry are as stated on Attach ment III as inseparable part of this Minister Regu lation. Article 17 (1) Quality examination as meant in Article 15 para graph (1) point a is done by accredited domestic laboratory in accordance to examination rules in Indonesia animal medicine pharmacopeia book, Indonesia pharmacopeia, other pharmacopeias, and/or other medicine analysis standard books. (2) Field trial as meant in Article 15 paragraph (1) point b is done by competent institution that in cludes efficacy or benefit test and/or safety test in accordance with fish medicine indications by d. country of origin of fish medicine sample; referring to field trial guidelines. 28 Business News 8337111-30-2012 t‘ R , " 71 '..:'..1..:V..1;',1%!4:16:4.4!'iN‘1,1',3;!.‘"P.t.*ts:10.,!t;%4 (3) Field trial as meant at paragraph (2) is performed g. information concerning container, wrapper, on seal; and a. fish medicine that contains active substance h. information concerning marking, in the form that never exists or has no homolog in lndone- of writing and/or picture put on container sia; andlor wrapper or label and brochure. b. fish medicine that indications and use have , (2) Fish medicine technical data form for stability ex not yet published and have not yet proven with official scientific reference. (4) Competent institution as meant at paragraph (2), is decided by Director General after fulfilling tech nical requirements, namely: a. facilities and infrastructure; b. human resources; and c. examination methods. (5) Extending laws on field trial guidelines as meant at paragraph (2) and technical requirements as meant at paragraph (4) are stipulated with Decree of Director General. Article 18 (11 Fish medicine technical data as meant in Article 15 paragraph (1) point c is stated on form con sists of: a. trade mark and composition of fish medicine; b. preparation manufacturing process of fish medicine; c. examination of fish medicine and raw material used; d. stability examination; e. pharmacology power; amination as meant at paragraph (1) point d, is not applicable for fish medicine: a. type of mineral in the form of powder with expiry date less than 1 (one) year; b. disinfectant; andlor c. natural materials. (3) Extending laws on procedures for fish medi cine technical form fill out as meant at para graph (1) are stipulated with Decree of Direc tor General. Article 19 (1) Director General performs evaluation on docu ment completeness within 2 (two) working days since the acceptance date of application as meant in Article 15 paragraph (1). (2) Based on the result of document completeness evaluation as meant at paragraph (1), Director General: a. forwards the documents stated as complete to Fish Medicine Assessment Team to be done technical evaluation upon; or b. issues rejection letter along with reason of rejection, if the documents are not com f. publication of clinical experiment in the field; 1 Mete. Business News 8337/11-30-2012 29 Niii;t11111011!"11114ii,rili>: .; R .HT-HATio , s ...i!!!"*SZPISIPti-Zm4i7H -10 (3) Fish Medicine Assessment Team, as meant at paragraph (2) point a perform technical evalua tion within 7 (seven) working days. (4) Technical evaluation as meant at paragraph (3), includes: a. scientific verification and analysis upon tech h. fish medicine classification; i. fish medicine form; j. fish medicine preparation type; k. fish medicine composition; I. package size; and m. Fish Medicine Registration Letter effective nical data stated in application documents; term. b. verification of quality examination result with (8) Form and format of Fish Medicine Registration technical data; and Letter is as stated on Attachment IV as insepa c. verification of field trial result with technical rable part of this Minister Regulation. data. (9) Extending laws on membership order and duties (5) Technical evaluation result as meant at paragraph of Fish Medicine Assessment Team as meant at (3) is in the form of recommendation and submit- paragraph (2) are stipulated with Decree of Direc ted to Director General. tor General. (6) Director General within 3 (three) working days since the acceptance date of recommendation as Article 20 meant in paragraph (5) must issue: (1) Fish medicine with same trade mark and composi a. Fish Medicine Registration Letter, for fish tion arrangement is given the same Fish Medicine medicine that meets requirements; or Registration Letter, even though with different b. Fish Medicine Registration Rejection Letter, package size. along with reason of rejection upon fish medi- (2) Fish medicine with different trade mark and/or cine that does not meet the requirements. (7) Fish Medicine Registration Letter as meant at paragraph (6) point a contains: a. fish medicine registration number; b. fish medicine producer/importer name; b. fish medicine producer/importer name; d. fish medicine production address; e. fish medicine producer name aboard; f. license grantor name; g. fish medicine trade mark/brand; composition arrangement is given different Fish Medicine Registration Letter. Article 21 (1) Upon rejected application as meant in Article 19 paragraph (2) point b or paragraph (6) point b, then applicant must retrieve the application docu ments within 15 (fifteen) working days. (2) If within 15 (fifteen) working days application documents are not retrieved by applicant, then 30 I Business News 8337/ 11-30-2012 G E t'AE Rf c U application becomes property of Directorate Gen eral of Fish Cultivation, Ministry of Marine Affairs and Fishery. Third Part Effective Term, Extension, and Replacement Article 22 Fish Medicine Registration Letter is effective for 5 (five) years since the issuance date. Article 23 (1) Effective term of Fish Medicine Registration Let ter as meant in Article 22 can be extended for the same period. (2) Extension application for Fish Medicine Registra tion Letter as meant at paragraph (1) can be done at the latest 3 (three) months prior the expiry date of Fish Medicine Registration Letter. (3) In order to obtain Fish Medicine Registration Let ter extension as meant at paragraph (1), producer or importer must apply written application to Di rector General along with: a. copy of Fish Medicine Registration Letter to be extended; b. latest quality test result report; c. technical data that includes: 1) trade mark and composition of fish medi cine; 2) manufacturing process of fish medicine preparation; that includes description, examination method, qualitative and quantitative ex amination result, attached with analysis certificate; 4) information concerning container, wrap per, seal; 5) information concerning marking, in the form of writing and/or picture put on con tainer wrapper or label and brochure; and 6) duty stamped statement letter from appli cant that there is change on composition and indication as well as method of use of fish medicine. (4) Extension mechanism of Fish Medicine Registra tion Letter in mutatis mutandis way referring to the provision of Article 19. Article 24 (1) Fish Medicine Registration Letter can be altered if there is change of administration data that in cludes: a. name of producer/importer; b. address of producer/importer; c. address of production place; d. name of license grantor; and/or e. trade mark/brand name of fish medicine; (2) In order to obtain Fish Medicine Registration Let ter change as meant at paragraph (1), producer or importer must submit application to Director General within 1 (one) month since the change of 3) examination of fish medicine preparation administration data exists along with: Business News 8337/11-30-2012 31 :PetSis .1 S 3at. ,TØRESEMIZEIntl. a. copy of Fish Medicine Registration Letter to be changed; and b. explanation of reason for administration data change. (3) Director General within 3 (three) working days since the acceptance date of application for ad ministration data change as meant in paragraph (1) performs document verification. (3) Director General issues replacement of Fish Medi cine Registration Letter within 3 (three) working days since the acceptance date of complete ap plication as meant in paragraph (2). Article 26 Producer or importer who has had Fish Medi cine Registration Letter is obliged to maintain fish (4) Based on the result of document verification as medicine quality consistency in accordance to infor meant at paragraph (3), Director General issues: mation stated on Fish Medicine Registration Letter. a. new copy of Fish Medicine Registration Let ter; or Article 27 b. Rejection Letter, along with reason of rejec- (1) Fish medicine from foreign country can be en tion. 1 tered into the territory of the State of Republic of (5) If new Fish Medicine Registration Letter has been Indonesia after obtaining Statement Letter of Fish issued, then within the same time applicant must Medicine Entry. return Fish Medicine Registration Letter on which I (2) In order to obtain Statement Letter of Fish Medi change has been done. Article 25 (1) Fish Medicine Registration Letter can be replaced if original Fish Medicine Registration Letter is damaged or lost. (2) In order to obtain replacement of Fish Medicine Registration Letter as meant at paragraph (1), producer or importer must submit application to Director General and attach original Fish Medicine cine Entry as meant at paragraph (1), importer or government/private institution must apply written application to Director General that at least con tains: a. fish medicine trade mark/brand; b. name and address of the applicant; c. name of fish medicine producer; d. country of origin of fish medicine; e. fish medicine classification; f. fish medicine form; 32 Registration Letter in case of damaged Fish Medi g. fish medicine preparation type; cine Registration Letter, or Statement Letter of h. package size; Kadit Serse from police in case the Fish Medicine i. purpose of fish medicine entry; Registration Number is lost. j. amount of fish medicine; Business News 8337/11-30-2012 Ma;:lb'ffaTartCtg!ti; (I'll NT R E C' bATHUNS k. loading port; and I. entry port. (3) Application submitted by importer as meant at paragraph 121, is attached with the following doc uments: a. copy of Fish Medicine Registration Letter; b. packing list that contains type, quantity, and volume/weight unit. 141 Application submitted by government/private in stitution as meant at paragraph (2), is attached with the following documents: a. copy of Certificate of Origin, and showing the original; b. copy of Certificate of Free Sale, and showing the original; c. copy of Certificate of Good Manufactur ing Practice from authority institution from the country of origin, and showing the original; d. copy of Certificate of Non-Genetically Modi fied Organism, for fish medicine of biologic preparation that is not modified genetically, and showing the original; e. technical data as meant in Article 15 para graph 111 point c, and f. packing list that contains type, quantity, and volume/weight unit. 161 Based on document evaluation as meant at para graph (5), Director General or appointed official issues: a. Statement Letter of Fish Medicine Entry; or b. Rejection Letter of Fish Medicine Entry, along with reason of rejection. 171 Statement Letter of Fish Medicine Entry as meant at paragraph (6) point a at least contains: a. fish medicine trade mark/brand; b. name of importer; c. address of importer; d. fish medicine registration number; e. name of fish medicine producer; f. country of origin of fish medicine; g. fish medicine classification; h. fish medicine form; i. fish medicine preparation type; j. package size; k. purpose of fish medicine entry; I. quantity of fish medicine; m. loading port; n. entry port; and o. effective term of Statement Letter of Fish Medicine Entry. 181 Statement Letter of Fish Medicine Entry as meant at paragraph 161 point a can only be used for 1 (one) time entry and valid for 3 (three) months 151 Director General or official appointed to perform since the issuance date. document evaluation within 3 (three) working 191 Form and format of Statement Letter of Fish Med days since the date of acceptance of the com- icine Entry are as stated on Attachment V as in plete documents. separable part of this Minister Regulation. Business News 8337/11-30-2012 33 a ; ; - RECULAJH.O1JS • 1.; ?nit,* CHAPTER VII ENTRY PROCEDURES FOR FISH MEDICINE RAW MATERIAL, FISH MEDICINE SAMPLE, AND FISH MEDICINE; Article 28 (1) importer of government/private institution that will enter fish medicine raw material, fish medi cine sample, and/or fish medicine into the terri tory of State of Republic of Indonesia is obliged to report within 1 (one) day prior to arrival and to submit Statement Letter of Fish Medicine Raw Material Entry, Statement Letter of Fish Medicine Sample Entry, and/or Statement Letter of Fish Medicine Entry to Quarantine Office on arrival time at entry place. (2) Quarantine Officer performs examination on Statement Letter of Fish Medicine Raw Material Entry, Statement Letter of Fish Medicine Sample Entry, and/or Statement Letter of Fish Medicine Entry as meant at paragraph (1) to find out valid ity and correctness of Statement Letter of Fish Medicine Raw Material Entry, Statement Letter of Fish Medicine Sample Entry, and/or Statement Letter of Fish Medicine Entry. (3) Statement Letter of Fish Medicine Raw Material Entry, Statement Letter of Fish Medicine Sample Entry, and/or Statement Letter of Fish Medicine Entry are stated valid if issued by Director General or appointed official. (4) Statement Letter of Fish Medicine Raw Material Entry, and/or Statement Letter of Fish Medicine Entry are stated correct if conform the physical of goods entered into the territory of State of Repub lic of Indonesia. (5) In the framework of examination of Statement Letter of Fish Medicine Raw Material Entry, State ment Letter of Fish Medicine Sample Entry, and/ or Statement Letter of Fish Medicine Entry as meant at paragraph (4), Quarantine Officer per forms physical check in customs area. (6) Examination of Statement Letter of Fish Medi cine Raw Material Entry, Statement Letter of Fish Medicine Sample Entry, and/or Statement Letter of Fish Medicine Entry as meant at paragraph (2) s done within 3 (three) working days. (7) Based on examination of Statement Letter of Fish Medicine Raw Material Entry, Statement Letter of Fish Medicine Sample Entry, and/ or Statement Letter of Fish Medicine Entry as meant at paragraph (2) and physical examina tion as meant at paragraph (5). Quarantine Of ficer issues: a. Approval Letter of Fish Medicine Raw Mate rial/Fish Medicine Sample/Fish Medicine Exit from Entry Port, if Statement Letter of Fish Medicine Raw Material Entry, Statement Let ter of Fish Medicine Sample Entry, and/or Statement Letter of Fish Medicine Entry are valid and correct, with copy to Director Gener al of Supervision of Marine Affairs and Fishery Entry, Statement Letter of Fish Medicine Sample Resources; or 34 Business News 8337/11-30-2012 GCHE RE i 10F, b. Rejection Letter of Fish Medicine Raw Mate rial/Fish Medicine Sample/Fish Medicine Exit from Entry Port, if Statement Letter of Fish Medicine Raw Material Entry, Statement Let ter of Fish Medicine Sample Entry, and/or Statement Letter of Fish Medicine Entry are not valid and correct. Article 29 (1) If fish medicine raw material, fish medicine sam ple, and/or fish medicine are imposed with rejec tion as meant in Article 28 paragraph (7) point b, then importer or government/private institution are obliged to resend the fish medicine raw mate rial, fish medicine sample, and/or fish medicine to country of origin within 3 (three) days since the rejection takes place. (2) If within 3 (three) days resending is not done to country of origin, then upon fish medicine raw material, fish medicine sample, and/or fish med icine as meant at paragraph (1) is performed elimination in accordance to provisions in ef fect. Article 30 Procedures for fish medicine raw material, fish medicine sample, and/or fish medicine entry of biologic preparation is exceptional from the provision CHAPTER VIII ENTRY AND EXIT PORT Article 31 Every fish medicines raw material, fish medi cine sample, or fish medicine to be imported into the territory of State of Republic of Indonesia or to be exported from the territory of State of Republic of In donesia can only be done through entry port and exit port as follows: a. seaport; Belawan in Medan, Tanjung Priok in Ja karta, Tanjung Emas in Semarang, Tanjung Perak in Surabaya, Soekarno Hatta in Makassar, and Panjang in Lampung; b. all international airport; and/or c. Entikong border cross checking post. CHAPTER IX FISH MEDICINE DISTRIBUTION Article 32 (1) Fish medicine distributed in the territory of State of Republic of Indonesia must be packed in air tight container and/or special wrap and mounted with information regarding fish medicine in Indo nesian that visible and readable and not easily erased. (2) Information concerning fish medicine as meant at paragraph (1) at least consists: a. fish medicine registration number; b. fish medicine producer/importer name and ad as meant in Article 28 and Article 29, and are regu- dress; lated with Minister Regulation. c. fish medicine trade mark/brand; Business News 8337/11-30-2012 135 NINIEFONOT•iraCrntlikirrikil GLM : EH P N v E m- R u L d. fish medicine classification; e. fish medicine form; f. fish medicine preparation type; g. fish medicine composition; h. net weight; i. allocation/indication and target fish; j. method of use and storage; k. production code; I. expiry date; and m. withdrawal time, especially for prescription drugs classification. Article 33 (1) Exporter who will circulate fish medicines to out side the territory of State of Republic of Indonesia must have Statement Letter of Fish Medicine Raw Exit. (2) In order to obtain Statement Letter of Fish Medi cine Exit as meant at paragraph 11), exporter must apply written application to Director General that at least contains: a. fish medicine trade mark/brand; b. name and address of the applicant; c. name of fish medicine producer; d. country of destination; e. fish medicine classification; f. fish medicine form; g. fish medicine preparation type; h. package size; U purpose of fish medicine exit; k. exit port. (3) Application submitted by exporter as meant at paragraph 12), is attached with the following doc uments: a. copy of Fish Medicine Registration Letter; and b. packing list that contains type, quantity, and volume/weight unit. (4) Director General or official appointed to perform document evaluation within 3 (three) working days since the acceptance date of complete ap plication. (5) Based on document evaluation as meant at para graph (4), Director General or appointed official issues: a. Statement Letter of Fish Medicine Exit; or b. Rejection Letter of Fish Medicine Exit, along with reason of rejection. (6) Statement Letter of Fish Medicine Exit as meant at paragraph (5) point a at least contains: a. fish medicine trade mark/brand; b. name and address of the exporter; c. fish medicine registration number; d. name of fish medicine producer; e. country of destination; f. fish medicine classification; g. fish medicine form; h. fish medicine preparation type; i. package size; i. purpose of fish medicine exit; k. quantity of fish medicine; j. fish medicine quantity; and I. exit port; and 36 Business News 8337/11-30-2012 jatitanatetStAWASViNiti: DVE R R (3! ................... -4:11th m. Statement Letter of Fish Medicine Exit effec- (1) Every Individual who will do reentry of fish medi tive term. eine raw medicine or fish medicine originated (7) Statement Letter of Fish Medicine Exit as meant from Indonesia because rejected by country of im at paragraph (5) point a can only be used for 1 porter/country of destination is obliged to report (one) time exit and valid for 3 (three) months within 1 (one) day prior to arrival to Quarantine since the issuance date. (8) Form and format of Statement Letter of Fish Med icine Exit are as stated on Attachment VI as in separable part of this Minister Regulation. Article 34 (1) Everybody is prohibited from circulating fish med icine that unfit for distribution. (2) Fish medicine that unfit for distribution as meant at paragraph (1) includes fish medicine that: a. does not have Fish Medicine Registration Let ter; b. experiences physical changes that includes texture, color, and/or smell; c. already expired; and/or d. package, container, wrapper and/or seal is damaged. Article 35 Everybody who does fish medicine business must perform recording upon every distributed fish medicine. CHAPTER X RE-ENTRY Officer and submits the following documents: a. Statement Letter of Fish Medicine Raw Mate rial Exit or Statement Letter of Fish Medicine Exit; and b. Goods Export Notification. (2) Quarantine Officer performs document evaluation as meant at paragraph (1) within 2 (two) working days to find out validity and correctness of docu ments. (3) Statement Letter of Fish Medicine Raw Material Exit or Statement Letter of Fish Medicine Exit, and Goods Export Notification are stated valid if issued by authorized institution. (4) Statement Letter of Fish Medicine Raw Material Exit or Statement Letter of Fish Medicine Exit and Goods Export Notification are stated correct if there is conformity between Statement Letter of Ash Medicine Raw Material Exit or Statement Letter of Fish Medicine Exit and Goods Export No tification with physical of reentry goods into the territory of State of Republic of Indonesia. (5) In the framework of correctness examination of Statement Letter of Fish Medicine Raw Material Exit or Statement Letter of Fish Medicine Exit, and Goods Export Notification, Quarantine Officer Article 36 performs physical examination in customs area. Business News 8337 / 11-30-2012 37 ! çJjQF . 71teeleeZelj, ,St ^ (6) Based on document evaluation result as meant at paragraph (2) and physical examination as meant at paragraph (5), Quarantine Officer issues: a. Approval Letter of Fish Medicine Raw Material Exit from Entry Port, if documents are com plete, valid, and correct, with copy to Director General of Supervision of Marine Affairs and Fisheries Resources; or b. Rejection Letter of Fish Medicine Raw Mate rial/Fish Medicine Exit from Entry Port, if doc uments are incomplete, invalid, and/or incor rect. (7) If fish medicine raw material or fish medicine is imposed with rejection act because documents are stated incomplete as meant at paragraph (6) point b, then owner of fish medicine raw material or fish medicine is obliged to complete the lack of documents within 3 (three) working days since the acceptance of Rejection Letter. documents are stated invalid and/or incorrect as meant at paragraph (6) point b, then fish medicine raw material or fish medicine are imposed with elimination. (10)Elimination as meant at paragraph (9) is per formed by Quarantine Officer. Article 37 Reentry of fish medicine raw material or fish medicine must through entry port decided as meant in Article 31. CHAPTER XI GUIDANCE, MONITORING, AND SUPERVISION Article 38 (1) Director General and Head of Office perform guid ance and monitoring upon provision and distribu tion of fish medicine in accordance to their re spective authority. (8) If within 3 (three) days since the acceptance of (2) Guidance and monitoring as meant at paragraph the Rejection Letter as meant at paragraph (6) point b owner of fish medicine raw material or fish medicine can complete the lack of docu ment, then in mutatis mutandis way provisions as meant at paragraph (2), paragraph (3), paragraph (4), and paragraph (5) are in effect. (9) If within 3 (three) days after the acceptance of Rejection Letter, owner of fish medicine raw ma terial or fish medicine cannot complete the lack of document or fish medicine raw material or fish (1), at least includes: a. process of provision and distribution of fish medicine; b. facilities and infrastructure of fish medicine storage; and c. quality, benefit, and safety of fish medicine. (3) In implementing guidance and monitoring as meant at paragraph (1), Director General or Head of Office decides Fish Medicine Guidance and Monitoring Team. medicine are imposed with rejection act because (4) Requirements to be member of Fish Medicine 38 Business News 8337/11-30-2012 Mtn %!..1:10;:ttleatial COVER HME T REC UL LCNS Guidance and Monitoring Team as meant at para graph (3) must have competency in fish medicine field. Article 39 (1) in the framework of fish medicine guidance and monitoring as meant in Article 38 paragraph (1), fish medicine producer is obliged to make report every 6 (six) months to Director General concern ing: a. quantity, type, and origin of raw material; b. quantity and type of fish medicine produced; and c. medicine quantity that has been distributed and area of distribution. (2) in the framework of fish medicine guidance and monitoring as meant in Article 38 paragraph (1), fish medicine importer is obliged to make report every 6 (six) months to Director General concern ing a. quantity and type of fish medicine that has been reentered into the territory of State of Republic of Indonesia; and b. fish medicine quantity that has been distrib uted and area of distribution. (3) in the framework of fish medicine guidance and monitoring as meant in Article 38 paragraph (1), exporter is obliged to make report every 6 (six) months to Director General concerning: a. quantity and type of fish medicine that has been exited from the territory of State of Re Business News public of Indonesia; and b. country of destination. (4) in the framework of fish medicine guidance and monitoring as meant in Article 38 paragraph (1), fish medicine distributor is obliged to make report every 6 (six) months to Head of Provincial Office concerning: a. quantity and type of fish medicine circulated; and b. fish medicine distribution business. (5) in the framework of fish medicine guidance and monitoring as meant in Article 38 paragraph (1), depot and fish medicine shop are obliged to make report every 6 (six) months to Head of Regency/ Municipal Office concerning: a. quantity and type of fish medicine distributed; b. name of prescription giver veterinarian; c. fish medicine distribution area; and d. name of fish medicine user for fish medicine in prescription drugs and limited free drugs classification. Article 40 (1) Head of Regency/Municipal Office submits report of fish medicine guidance and monitoring result to Head of Provincial Office on 10th of the next month. (2) Head of Provincial Office submits report of fish medicine guidance and monitoring result to Direc tor General at the latest on 20th that contains result of guidance and monitoring he performed 11-30-2012 39 graph (2) is used by Director General as material to make policy. Article 44 Article 41 Supervision upon fish medicine distribution is performed by Fishery Supervisor. CHAPTER XII SANCTION Article 42 (1) Fish medicine producer or importer who violates Article 26, Article 35, and/or Article 39 is im posed with administrative sanction. (2) Administrative sanction as meant at paragraph (1) can be in the form of: a. written warning; b. freeze of Fish Medicine Registration Letter; or (1) Administrative sanction in the term of freeze of Fish Medicine Registration Letter as meant in Ar ticle 42 paragraph (2) point b is given to: a. producer or importer of fish medicine as meant in Article 44 paragraph (1) that until the end of time period of third warning does not perform the obligations; b. producer or importer of fish medicine who violates the provision as meant in Article 26. (2) Freeze of Fish Medicine Registration Letter as meant at paragraph (1), is carried out for 30 (thir ty) days since the sanction imposed. Article 45 administrative sanction in the form of revoca c. revocation of Fish Medicine Registration Let- tion of Fish Medicine Registration Letter as meant in ter. Article 42 paragraph (2) point c is given to producer (3) Administrative sanction as meant at paragraph (2) or importer that until the expiry date of the freeze of is given by Director General. Fish Medicine Registration Letter does not perform the obligations. Article 43 (1) Written warning as meant in Article 42 paragraph (2) point a is given to producer or to importer of fish medicine that violates provision as meant in Article 35 and/or Article 39. CHAPTER XIII EXPIRY OF FISH MEDICINE REGISTRATION LETTER Article 46 (1) Fish Medicine Registration Letter as meant in Arti (2) Written warning as meant at paragraph (1) is giv- cle 19 at paragraph (6) point a is expired because: 40 Business News 8337111-30-2012 a. revoked because producer or importer of fish medicine until the expiry of freeze of Fish Medicine Registration Letter does not perform the obligations; b. revoked due to request of the owner of Fish Medicine Registration Letter; c. revoked because scientifically proven or based on other references the fish medicine is harm ful for the health of fish, human, and environ ment; d. effective term of Fish Medicine Registration Letter is due and not extended. (2) Revoked of Fish Medicine Registration Letter as meant at paragraph (1) point a, point b, and point c is performed by Director General. CHAPTER XIV OTHER PROVISIONS Article 47 (1) In emergency condition and/or plague that has (1) point c and requirements as meant in Article 15 paragraph (2) for fish medicine from foreign country. (3) Director General performs evaluation on docu ment completeness within 1 (one) working days since the acceptance date of application as meant at paragraph (2). (4) Based on the result of evaluation on document completeness as meant at paragraph (3), Director General forwards documents stated as complete to Fish Medicine Assessment Team to be done technical evaluation upon. (5) Based on technical evaluation as meant at para graph (4), within 2 (two) working days, Fish Med icine Assessment Team gives recommendation to Director General that contains approval or rejec tion. (6) Director General within 2 (two) working days since the acceptance date of recommendation as meant in paragraph (5) must issue: been decided by the Minister and there is no fish a. Temporary Fish Medicine Registration Letter, for medicine with Fish Medicine Registration Letter fish medicine that fulfills requirements; or to take care of the emergency condition and/or b. Rejection Letter, along with reason of rejection plague, then fish medicine that fulfills the require ments can be given Temporary Fish Medicine Registration Letter. (2) In order to obtain Fish Medicine Registration Let ter as meant at paragraph (1), producer or im upon fish medicine that does not fulfill the re quirements. Article 48 porter must submit written application to Director Fish Medicine Registration Letter as meant in General completed with explanation concerning Article 47 at paragraph (6) point a is effective for 1 technical data as meant in Article 15 paragraph (one) year. Business News 8337111-30-2012 I 41 .4*** „:74":"4,. uovrpr...., ,,,, E.N R.EGuL.AT , oNs . CHAPTER XV TRANSITIONAL PROVISIONS Article 49 (1) In case regulation concerning CPOIB as meant in Article 12 paragraph (4) has not been stipu lated, then the manufacturing of fish medicine is referring to Good Animal Medicine Manufacturing Practice (CPOHB). is revoked and declared null and void. Article 51 This Minister Regulation starts to take effect since the promulgation date. For everybody to acknowledge this regula tion, ordering the promulgation of this Minister Regu lation to be placed in the State Gazette of Republic of (2) Fish Medicine Registration Letter that has been is- Indonesia. sued prior to the stipulation of this Minister Regu lation is stated as still effective up to the expiry date. (3) Application for Fish Medicine Registration Letter submitted and stated complete is processed based on the Decree of Minister of Maritime Affairs and Fisheries Number KEP.26/MEN/2002 concerning Provision, Distribution, Usage, and Supervision of Stipulated in Jakarta on 31 January 2012 THE MINISTER OF MARINE AFFAIRS AND FISHERY THE REPUBLIC OF INDONESIA, Sgnd. SHARIF C. SUTARDJO Fish Medicine. Promulgated in Jakarta on 1 February 2012 CHAPTER XVI THE MINISTER OF LAW AND HUMAN RIGHTS FINAL PROVISIONS Article 50 With the stipulation of this Minister Regula tion, then Minister of Maritime Affairs and Fisheries Number KEP.26/MEN/2002 concerning Provision, Distribution, Usage, and Supervision of Fish Medicine THE REPUBLIC OF INDONESIA, Sgnd. AMIR SYAMSUDIN THE STATE GAZETTE OF REPUBLIC OF INDONESIA YEAR 2012 NUMBER 139 42 I Business News 8337/11-30-2012 ftag f .1 O f tif f RELLATkDN c eta a ATTACHMENT I: THE REGULATION OF MINISTER OF MARINE AFFAIRS AND FISHERY OF REPUBLIC OF INDONESIA NUMBER PER.04/MEN/2012 CONCERNING FISH MEDICINE STATEMENT LETTER OF FISH MEDICINE RAW MATERIAL ENTRY NUMBER: In connection with application from Number: date and based on result of evaluation performed, hereby the Director General of Fish Cultivation of Ministry of Marine Affairs and Fishery of Republic of Indonesia basically approves the entry of fish medicine raw material by: ' Name of importer or government/private institution; Address of importer or government/private institution; With the following details: a. name of fish medicine raw material b. name of fish medicine raw material producer c. country of origin of fish medicine raw material . • d. form of fish medicine raw material . • e. preparation type of fish medicine raw material . • f. package size . • g. purpose of fish medicine raw material entry . • h. quantity of fish medicine raw material . • i. loading port . • j. entry port. This Statement Letter of Fish Medicine Raw Material Entry is valid only for 1 (one) time fish medicine raw material entry. This Statement Letter of Fish Medicine Raw Material Entry is valid for 3 (three) months as of the date of issuance and cannot be transferred to other party. Jakarta Director General of Fish Cultivation Business News 8337/ 11-30-2012 I 43 Copy to: 1. Director General of Control of Marine Affairs and Fisheries Resources; 2. Head of Agricultural Quarantine Agency, Quality Control, and Safety of Fishery Product; • 3. UPT Head of Agricultural Quarantine Agency, Quality Control, and Safety of Fishery Product 4. Head of Supervision and Service Office of Customs and Excise THE MINISTER OF MARINE AFFAIRS AND FISHERY THE REPUBLIC OF INDONESIA, Sgnd. SHARIF C. SUTARDJO ATTACHMENT II: THE REGULATION OF MINISTER OF MARINE AFFAIRS AND FISHERY OF REPUBLIC OF INDONESIA NUMBER PER.04/MEN/2012 CONCERNING FISH MEDICINE STATEMENT LETTER OF FISH MEDICINE RAW MATERIAL EXIT NUMBER: In connection with application from Number: date and based on result of evaluation performed, hereby the Director General of Fish Cultivation of Ministry of Marine Affairs and Fishery of Republic of Indonesia basically approves the exit of fish medicine raw material by: • Name of exporter Address of exporter : with the following details: a. name of fish medicine raw material b. name of fish medicine raw material producer c. country of destination d. form of fish medicine raw material e. preparation type of fish medicine raw material 44 Business News 8337/11 30-2012 G EIVERNMENIT REGULAMIDNS f. package size g. purpose of fish medicine raw material exit h. quantity of fish medicine raw material I. exit port This Statement Letter of Fish Medicine Raw Material Exit is valid only for 1 (one) time fish medicine raw material exit. Statement Letter of Fish Medicine Raw Material Exit is valid for 3 (three) months as of the date of is suance and cannot be transferred to other party Jakarta, Director General of Fish Cultivation Copy to: 1. Director General of Control of Marine Affairs and Fisheries Resources; 2. Head of Agricultural Quarantine Agency, Quality Control, and Safety of Fishery Product; 3. UPT Head of Agricultural Quarantine Agency, Quality Control, and Safety of Fishery Product • 4. Head of Supervision and Service Office of Customs and Excise THE MINISTER OF MARINE AFFAIRS AND FISHERY THE REPUBLIC OF INDONESIA, Sgnd. SHARIF C. SUTARDJO Business News 8337/11-30-2012 45 ATTACHMENT III : THE REGULATION OF MINISTER OF MARINE AFFAIRS AND FISHERY OF REPUBLIC OF INDONESIA NUMBER PER.04/MEN/2012 CONCERNING FISH MEDICINE STATEMENT LETTER OF FISH MEDICINE SAMPLE ENTRY NUMBER: In connection with application from Number: date and based on result of evaluation performed, hereby the Director General of Fish Cultivation of Ministry of Marine Affairs and Fishery of Republic of Indonesia basically approves the entry of fish medicine sample by: Name of importer Address of importer with the following details: • a. trade mark/brand of fish medicine sample . • b. name of fish medicine sample producer . • c. country of origin of fish medicine sample . • d. composition of fish medicine sample . • e. form of fish medicine sample . • f. preparation type of fish medicine sample . • g. package size . • h. purpose of entry . • i. quantity of fish medicine sample . • j. loading port . • k. entry port . This Statement Letter of Fish Medicine Sample Entry is valid only for 1 (one) time fish medicine sample entry. Statement Letter of Fish Medicine Sample Entry is valid for 3 (three) months as of the date of issuance and cannot be transferred to other party. 46 Business News 8337/11-30-2012 Jakarta Director General of Fish Cultivation Copy to: 1. Director General of Control of Marine Affairs and Fisheries Resources; 2. Head of Agricultural Quarantine Agency, Quality Control, and Safety of Fishery Product; 3. UPT Head of Agricultural Quarantine Agency, Quality Control, and Safety of Fishery Product 4. Head of Supervision and Service Office of Customs and Excise THE MINISTER OF MARINE AFFAIRS AND FISHERY THE REPUBLIC OF INDONESIA, Sgnd. SHARIF C. SUTARDJO ATTACHMENT )V: THE REGULATION OF MINISTER OF MARINE AFFAIRS AND FISHERY OF REPUBLIC OF INDONESIA NUMBER PER.04/MEN/201 2 CONCERNING FISH MEDICINE DIRECTOR GENERAL OF FISH CULTIVATION FISH MEDICINE REGISTRATIDN LETTER NUMBER . Based on technical evaluation result by Directorate General of Fish Cultivation, then fish medicine from: • a. name of fish medicine producer/importer . • b. complete address of fish medicine producer/importer . • c. location address of fish medicine production . • d. Name of fish medicine producer aboard • Business News 8337111-30-2012 I 47 wSk 'Cc • SIMC RC,- I AT •i •y. ye. yejt...,,S att. gas e. name of license grantor f. trade mark/brand of fish medicine g. classification of fish medicine h. form of fish medicine i. preparation type of fish medicine j. composition of fish medicine k. package size stated CAN be provided, be distributed, and be used throughout the territory of Republic of Indonesia. This Fish Medicine Registration Letter is valid for 5 (five) years as of the date of issuance and cannot be transferred to other party. Jakarta Director General of Fish Cultivation THE MINISTER OF MARINE AFFAIRS AND FISHERY THE REPUBLIC OF INDONESIA, Sgnd. SHARIF C. SUTARDJO ATTACHMENT V: to be continued (A) 48 1 Business News 8337/11-30-2012 MatgarETAWA :;;;Rtilejl GOVERNMENT RE t " - taltaWatC,W,M,Srs; FISH MEDICATION (The Regulation of Minister of Marine Affairs and Fishery of RI Number PER.04/MEN/2012, dated 31 January 2012) [Continued from Business News No. 8337 page 19-481 ATTACHMENT V: THE REGULATION OF MINISTER OF MARINE AFFAIRS AND FISHERY OF REPUBLIC OF INDONESIA NUMBER PER.04/MEN/2012 CONCERNING FISH MEDICINE STATEMENT LETTER OF FISH MEDICINE ENTRY NUMBER: In connection with application from Number: date and based on result of evaluation performed, hereby the Director General of Fish Cultivation of Ministry of Marine Affairs and Fishery of Republic of Indonesia basically approves the entry of fish medicine by: Name of importer Address of importer with the following details: a. trade mark/brand of fish medicine b. number of fish medicine registration c. name of fish medicine producer d. country of origin of fish medicine e. classification of fish medicine f. form of fish medicine g. preparation type of fish medicine h. package size; i. purpose of fish medicine entry j, quantity of fish medicine Business News 8340112-7-2012 I 31 GOVERNMENT REGULATIONS :• k. loading port I. entry port This Statement Letter of Fish Medicine Entry is valid only for 1 (one) time fish medicine sample entry. This Statement Letter of Fish Medicine Entry is valid for 3 (three) months as of the date of issuance and cannot be transferred to other party. Jakarta, Director General of Fish Cultivation Copy to: 1. Director General of Control of Marine Affairs and Fisheries Resources; 2. Head of Agricultural Quarantine Agency, Quality Control, and Safety of Fishery Product; 3. UPT Head of Agricultural Quarantine Agency, Quality Control, and Safety of Fishery Product 4. Head of Supervision and Service Office of Customs and Excise THE MINISTER OF MARINE AFFAIRS AND FISHERY THE REPUBLIC OF INDONESIA, Sgnd. SHARIF C. SUTARDJO 32 Business News 8340/12-7-2012 ATTACHMENT VI: THE REGULATION OF MINISTER OF MARINE AFFAIRS AND FISHERY OF REPUBLIC OF INDONESIA NUMBER PER.04/MEN/2012 CONCERNING FISH MEDICINE STATEMENT LETTER OF FISH MEDICINE EXIT NUMBER: In connection with application from Number: date and based on result of evaluation performed, hereby the Oirector General of Fish Cultivation of Ministry of Marine Affairs and Fishery of Republic of Indonesia basically approves the exit of fish medicine by: Name of exporter Address of exporter with the following details: a. trade mark/brand of fish medicine b. number of fish medicine registration c. name of fish medicine producer d. country of destination e. classification of fish medicine f. form of fish medicine g. preparation type of fish medicine h. package size; I. purpose of fish medicine exit j. quantity of fish medicine k, exit port This Statement Letter of Fish Medicine Exit is valid only for 1 (one) time fish medicine exit. This Statement Letter of Fish Medicine Exit is valid for 3 (three) months as of the date of issuance and , cannot be transferred to other party. Business News 8340/12-7-2012 33 Jakarta Director General of Fish Cultivation Copy to: 1. Director General of Control of Marine Affairs and Fisheries Resources; 2. Head of Agricultural Quarantine Agency, Quality Control, and Safety of Fishery Product; 3. UPT Head of Agricultural Quarantine Agency, Quality Control, and Safety of Fishery Product • 4. Head of Supervision and Service Office of Customs and Excise THE MINISTER OF MARINE AFFAIRS AND FISHERY THE REPUBLIC OF INDONESIA, Sgnd. SHARIF C. SUTARDJO ( A ) 34 Business News 8340/12-7-202